The present invention relates to a method and device for treating functional bladder disorders and related disorders in women by administering a therapeutic composition to the trigone of the bladder through the vagina.
The bladder functions to store urine and at appropriate times under voluntary control to void urine and hence empty to completion in an efficient and timely manner. The storage and voiding functions of the bladder are under neural control. The innervation of the bladder is primarily autonomic with the parasympathetic system thought to dominate during voiding and the sympathetic system dominating during the storage phase. However the innervation of the bladder is complex and many of the mechanisms of storage and voiding are poorly understood. In particular there is much local interplay of complex neuronally active molecules especially related to the sensory mechanisms.
Functional disorders of the bladder interfere with the normal storage or voiding functions. Many of the functional disorders of the bladder can be treated pharmacologically. Most treatments of functional disorders are systemic with the resultant adverse effect due to pharmacological action in other body systems. Local therapy has been carried out by injection into structures of the bladder by direct visualization of the internal structure of the bladder through a cystoscope. While this method allows accurate anatomic placement of the therapeutic agent, it does require expertise in cystoscopy, consequently limiting the number of healthcare providers who can administer this type of therapy.
Local therapy would be preferred as it would avoid adverse events from distal systems at risk from systemic therapy and would allow the use of therapeutic agents that would otherwise be toxic if administered systemically. The neuronal supply to the bladder is profuse at the neck of the bladder, near the region known as the trigone. Consequently, this is an ideal site for local administration of therapeutic agents. However, local administration of drug to the bladder has been limited by the need to use a cystoscope. To date, the trigone has not been accessed via the vagina for the purposes of pharmacological treatment. The present invention provides a novel method and device for accessing the trigone for local application of therapeutic compounds to the bladder.